Nasal Vaccine for Respiratory Syncytial Virus

Not currently recruiting at 4 trial locations

Overseen By Clinical Operations

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Codagenix, Inc

Must not be taking: Immunosuppressive agents, Chemotherapy

Disqualifiers: Immunocompromised, Asthma, Transplant, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new nasal vaccine, CodaVax-RSV, to assess its safety and effectiveness in boosting the immune system against respiratory syncytial virus (RSV), a common virus affecting the lungs and breathing. Children will receive two doses of the vaccine or a placebo, with their health and immune response monitored. The trial seeks generally healthy children, born full-term, in two age groups: 2-5 years with past RSV exposure or 6 months to under 2 years without RSV exposure. Parents will track their child's health in a diary, and regular check-ups will ensure safety. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new vaccine.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether participants must stop taking their current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that RSV vaccines, such as CodaVax-RSV, aim to prevent illnesses caused by the respiratory syncytial virus. The safety of CodaVax-RSV in humans remains under investigation, as it is in the early testing stages.

These initial tests focus on ensuring the vaccine's safety and observing the body's response. Tests with other RSV vaccines, like ChAd155-RSV, showed they were as safe as other common childhood vaccines, generally well-tolerated with no serious side effects reported. Based on these findings, CodaVax-RSV is expected to be similarly safe, but ongoing studies must confirm this.

Prospective trial participants should know that researchers closely monitor them. Regular check-ins and safety reviews are integral to the study to ensure participants' well-being. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about CodaVax-RSV because it offers a novel approach to preventing respiratory syncytial virus (RSV) infections. Unlike traditional RSV treatments, which often involve supportive care or monoclonal antibodies like palivizumab, CodaVax-RSV is a live attenuated vaccine administered as nose drops. This delivery method could potentially make it easier and more comfortable, especially for young children. Additionally, by using a live attenuated virus, the vaccine aims to stimulate a strong immune response, potentially providing better protection against RSV.

What evidence suggests that CodaVax-RSV might be an effective treatment for RSV?

Research has shown that vaccines for RSV (Respiratory Syncytial Virus) hold promise in preventing illness caused by the virus. Some RSV vaccines have proven to be over 60% effective in stopping RSV-related breathing problems. The CodaVax-RSV vaccine, a live attenuated vaccine, is being tested in various dosages in this trial to determine its effectiveness. This type of vaccine uses a weakened form of the virus to help the body build immunity without causing the disease. Early results from similar vaccines suggest they can significantly reduce severe RSV infections. Although CodaVax-RSV remains under study, it is designed to trigger a strong immune response, potentially leading to effective protection against RSV. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for healthy children who had a full-term birth. Kids aged 2-5 with RSV antibodies and those 6 months to under 2 years without these antibodies can join. They shouldn't be in close contact with certain vulnerable individuals or have conditions affecting their immune system.

Inclusion Criteria

Part A: 2 to 5 years, inclusive

Part B: RSV-seronegative

Product of normal full-term pregnancy (36 to 42 weeks gestation)

Exclusion Criteria

Pregnant women

Household contact of another child enrolled into the study

I am currently taking medication that weakens my immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 doses of the CodaVax-RSV vaccine or placebo, 28 days apart, administered as nose drops

8 weeks

8 visits (in-person), multiple phone contacts

Follow-up

Participants are monitored for safety and immune response through the 2023-24 RSV season, with monthly phone contacts until 1 year after the second dose

12 months

Monthly phone contacts

What Are the Treatments Tested in This Trial?

Interventions

• CodaVax-RSV

Trial Overview The study tests CodaVax-RSV, a vaccine given as nose drops to prevent Respiratory Syncytial Virus (RSV). Children will get either the vaccine at different doses or a placebo, across two shots spaced by 28 days. Their health will be monitored over the RSV season.

How Is the Trial Designed?

Group I: Experimental: CodaVax-RSV 10^6 PFU Experimental Treatment 1 Intervention

Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops

Group II: Experimental: CodaVax-RSV 10^5 PFU Experimental Treatment 1 Intervention

Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops

Group III: Experimental: CodaVax-RSV 10^4 PFU Experimental Treatment 1 Intervention

Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops

Group IV: Experimental: CodaVax-RSV 10^3 PFU Experimental Treatment 1 Intervention

Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops

Group V: Placebo comparator Placebo Group 1 Intervention

Administered as nose drops

CodaVax-RSV is already approved in United States for the following indications:

Approved in United States as CodaVax-RSV for:

• Prevention of respiratory syncytial virus (RSV) infection in infants and toddlers

Who Is Running the Clinical Trial?

Codagenix, Inc

Lead Sponsor

Trials

8

Recruited

380+

Published Research Related to This Trial

The RSV001 trial is a phase 1 study involving 70 healthy adults (ages 18-75) to evaluate the safety and immunogenicity of two novel RSV vaccines, PanAd3-RSV and MVA-RSV, using various prime/boost combinations.

Initial safety assessments showed that participants will monitor for adverse events for one week post-vaccination, ensuring that the vaccines are safe for both younger and older adults, which is crucial given the high-risk nature of RSV infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of novel respiratory syncytial virus (RSV) vaccines based on the RSV viral proteins F, N and M2-1 encoded by simian adenovirus (PanAd3-RSV) and MVA (MVA-RSV); protocol for an open-label, dose-escalation, single-centre, phase 1 clinical trial in healthy adults. Green, CA., Scarselli, E., Voysey, M., et al.[2019]

In a study of 26 pediatric patients with rattlesnake envenomation treated with Crotalidae equine immune F(ab') 2 antivenom (F(ab') 2 AV), the treatment was found to be well tolerated, with only two patients experiencing mild infusion reactions that were easily managed.

No serious complications, recurrent symptoms, or readmissions were reported after discharge, indicating that F(ab') 2 AV is a safe and effective option for treating rattlesnake bites in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Rattlesnake Envenomations Treated With Crotalidae Equine Immune F(Ab') 2 Antivenom : A 3-Year Retrospective Observational Analysis. Seltzer, JA., Winkler, GA., Friedman, NA., et al.[2023]

In a study of 12 pediatric patients treated for rattlesnake bites, Crotalinae polyvalent immune Fab (ovine) antivenom was found to be safe, with no allergic reactions or permanent side effects reported.

The antivenom effectively controlled symptoms of envenomation, with severity scores stabilizing or improving within 24 hours after administration, using an average of 7.7 vials for initial symptom control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Crotaline Fab antivenom for the treatment of children with rattlesnake envenomation. Offerman, SR., Bush, SP., Moynihan, JA., et al.[2019]

The investigational ChAd155-RSV vaccine was found to have a safety profile similar to other childhood vaccines, with most adverse events occurring at rates comparable to or lower than those of active comparators.

The vaccine induced a strong immune response in infants, with higher RSV neutralizing titers and antibody concentrations compared to the comparator group, and there was no evidence of vaccine-associated enhanced respiratory disease (VAERD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a ChAd155-vectored respiratory syncytial virus vaccine in infants 6-7 months of age: a phase 1/2 randomized trial. Sáez-Llorens, X., Norero, X., Mussi-Pinhata, MM., et al.[2023]

The ChAd155-RSV vaccine was well tolerated in a phase I/II trial with 82 RSV-seropositive children aged 12-23 months, showing no serious adverse events or RSV-related hospitalizations over a 2-year follow-up.

A dose-dependent immune response was observed, with increased RSV-A neutralizing antibody titers after the first dose, but no significant boost in antibody levels after the second dose, indicating the need for further studies in RSV-seronegative children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Immunogenicity of a ChAd155-Vectored Respiratory Syncytial Virus (RSV) Vaccine in Healthy RSV-Seropositive Children 12-23 Months of Age. Díez-Domingo, J., Sáez-Llorens, X., Rodriguez-Weber, MA., et al.[2023]

In a phase 2a trial with 63 healthy participants aged 18 to 50, the MVA-BN-RSV vaccine significantly reduced viral load and symptoms of RSV infection compared to placebo, demonstrating an efficacy of 79.3% to 88.5%.

The vaccine also induced strong immune responses, with a fourfold increase in antibody levels and a significant rise in interferon-γ-producing cells, while only causing mild side effects like injection site pain and no serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced Respiratory Syncytial Virus Load, Symptoms, and Infections: A Human Challenge Trial of MVA-BN-RSV Vaccine. Jordan, E., Kabir, G., Schultz, S., et al.[2023]

The RSVNanoVax vaccine candidate, developed using polyanhydride nanoparticles and the RSV prefusion F protein, successfully induced long-lasting immunity in outbred Swiss Webster mice, with protective antibody responses sustained for at least 1 year post-vaccination.

Vaccinated mice showed rapid clearance of the RSV virus from their lungs after challenge, indicating that RSVNanoVax could provide effective protection against respiratory syncytial virus infections in a genetically diverse population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Lasting Protection Induced by a Polyanhydride Nanovaccine against Respiratory Syncytial Virus in an Outbred Mouse Model. Stephens, LM., Ross, KA., McLellan, JS., et al.[2023]

The study developed a human monoclonal antibody (mAb 6-137) that specifically targets the H7 hemagglutinin (HA) of the H7N9 virus, showing high affinity and effective neutralization in vitro at very low concentrations (as low as 78 ng/mL).

In murine models, mAb 6-137 provided significant protection against lethal H7N9 virus challenges, indicating its potential as both a preventive and therapeutic treatment option for H7N9 infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A broadly neutralizing human monoclonal antibody against the hemagglutinin of avian influenza virus H7N9. Li, J., Zhang, L., Bao, L., et al.[2022]

The implementation of a nationally developed snakebite treatment protocol in India led to a 66% reduction in the amount of anti-snake venom (ASV) used, indicating more efficient use of resources in treating snakebite victims.

The protocol also correlated with a trend towards reduced mortality, showing an absolute reduction of 24%, suggesting that structured treatment guidelines can improve patient outcomes in snakebite cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A locally developed snakebite management protocol significantly reduces overall anti snake venom utilization in West Bengal, India. Ghosh, S., Maisnam, I., Murmu, BK., et al.[2008]

In a study of 176 snake bite patients, neurotoxic snake bites were identified as a significant risk factor for mortality, indicating that these types of bites pose a greater threat to patient survival.

The study found that early adverse reactions to anti-snake venom (ASV) occurred in only 4% of patients, and most received premedication with corticosteroids, suggesting that ASV is generally safe but may be less effective for neurotoxic bites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective study of use of polyvalent anti-snake venom and risk factors for mortality from snake bite in a tertiary care setting. Pore, SM., Ramanand, SJ., Patil, PT., et al.[2018]

The Ad26.RSV.preF vaccine candidate showed good safety and immunogenicity in a study involving 12 adults and 36 RSV-seropositive children, with no serious adverse events reported and only mild to moderate reactions observed.

The vaccine significantly increased RSV neutralization titers in children and resulted in fewer RSV infections compared to the placebo group, indicating its potential effectiveness in preventing RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1/2a Safety and Immunogenicity of an Adenovirus 26 Vector Respiratory Syncytial Virus (RSV) Vaccine Encoding Prefusion F in Adults 18-50 Years and RSV-Seropositive Children 12-24 Months. Stuart, ASV., Virta, M., Williams, K., et al.[2023]

The PanAd3-RSV and MVA-RSV vaccines were found to be safe and well tolerated in a phase 1 clinical trial involving 42 healthy adults, with only mild injection site reactions reported and no serious adverse events.

Both vaccines effectively induced immune responses, including increased RSV neutralizing antibodies and T cell responses, suggesting they could be promising candidates for further evaluation in preventing RSV infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chimpanzee adenovirus- and MVA-vectored respiratory syncytial virus vaccine is safe and immunogenic in adults. Green, CA., Scarselli, E., Sande, CJ., et al.[2023]

Citations

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Respiratory syncytial virus (RSV) vaccine effectiveness and ... Clinical trials have demonstrated the efficacy of RSV vaccines (62.1% for ABRYSVO and 71.7% for AREXVY) against RSV-related acute respiratory illness in this ...

2. academic.oup.com academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaf496/8293665

Estimated Vaccine Effectiveness for Respiratory Syncytial ... The RSVpreF vaccine was 92% effective against respiratory syncytial virus–related acute respiratory illness emergency department ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828028

Estimated Vaccine Effectiveness for Respiratory Syncytial ... In our primary analysis, RSVpreF effectiveness was 89% against RSV-related LRTD requiring hospitalization or ED visit among adults aged 60 years ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11724408/

The recent landscape of RSV vaccine research - PMC Recently, a new mAb, nirsevimab, showed great promise in protecting infants from RSV and is longer acting, highly effective, has no significant ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1473309924007965

Respiratory syncytial virus vaccine effectiveness among ... Two observational studies conducted in the USA showed vaccine effectiveness of 75–80% against RSV-associated hospitalisation. Added value of this study. Using ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04919109

NCT04919109 | Safety and Immunogenicity of CodaVax- ... This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety of and immune response to CodaVax- ...

7. cdc.gov cdc.gov/vaccines/hcp/current-vis/rsv.html

RSV Vaccine VIS RSV vaccine can prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV). RSV is a common respiratory virus that usually causes mild ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10786261/

Safety and Immunogenicity of a ChAd155-Vectored ... ChAd155-RSV administered to 6- to 7-month-olds had a reactogenicity/safety profile like other childhood vaccines, showed no evidence of VAERD, and induced a ...

9. academic.oup.com academic.oup.com/ofid/article/11/9/ofae453/7730187

A Phase 1/2a Study Evaluating Safety and Immunogenicity of ... In this phase 1/2a study, 3 doses of the Ad26.RSV.preF vaccine (2.5 × 1010 vp) was well tolerated and elicited an immunogenic response in ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S2590136225001251

Real-world data and clinical management experience in ... The vaccine targets the RSV pre-fusion F protein, eliciting an immune response that provides protection against lower respiratory tract disease ...